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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AUTOSOFT 90; INSET II 60/9 GREY TCAP
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AUTOSOFT 90; INSET II 60/9 GREY TCAP Back to Search Results
Lot Number 5247396
Medical Device Problem Code Material Twisted/Bent (2981)
Health Effect - Clinical Code Elevated ketones/Diabetic Ketoacidosis (2364)
Type of Reportable Event Serious Injury
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the united states.The patient reported having bent cannula issues in the past with 8 infusion sets.The patient experienced diabetic ketoacidosis and high blood glucose level reported to be above 600 mg/dl.The patient self-treated it with a bolus via pump.Subsequently, she was hospitalized and received insulin via intravenous route, which resolved the issue.There was no permanent damage to the patient.The infusion set had been in use for approximately one day.The patient stayed in the hospital for two days.Unomedical do not see bent/kinking as being related to human factors, but rather as a training issue including correct choices of insertion sites and infusion sets and cannula length.Furthermore, the soft cannula is a flexible material that during use and upon removal can bend slightly.No further information available.
 
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Brand Name
AUTOSOFT 90
Common Device Name
INSET II 60/9 GREY TCAP
MDR Report Key8447376
Report Number3003442380-2019-00654
Device Sequence Number429606
Product Code FPA
UDI-Device Identifier05705244014367
UDI-Public05705244014367
Combination Product (Y/N)N
PMA/510(K) Number
K032854
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device No Information
Device Expiration Date07/01/2021
Device Lot Number5247396
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/28/2019
Initial Report FDA Received Date03/25/2019
Patient Sequence Number1
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